Orphan Indications for CD19 Redirected Autologous T Cells

This is an open-label, four-cohort, phase 2 study to determine the efficacy of CART19 in pediatric and young adult patientswith hypodiploid (Cohort A) or t(17;19) B-ALL (Cohort B), infants with very high risk KMT2A B-ALL (Cohort C), and in patients with central nervous system (CNS) relapse who did not receive cranial radiation (XRT) or bone marrow transplantation (BMT) (Cohort D).

Trial Details

NCT ID
NCT04276870
Phase
PHASE2
Sponsor
Stephan Grupp MD PhD
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Murine CART19
Locations (sample)
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362

Key Eligibility Criteria

  • Signed informed consent form must be obtained prior to any study procedure.
  • Male and female patients with documented CD19+ B-ALL
  • a.Cohort A \& B: Patients, regardless their response to initial or relapsed B ALL therapy, with the following characteristics: i.Cohort A: Subjects…
  • c.Cohort D: Subjects in a first or greater CNS relapse, prior to therapy with cranial XRT or HSCT for the current relapse

For full eligibility, visit ClinicalTrials.gov.

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